Effects of Imatinib Mesylate in Polycythemia Vera

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00430066
First received: January 31, 2007
Last updated: June 18, 2012
Last verified: October 2007
  Purpose

The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.


Condition Intervention Phase
Polycythemia Vera
Drug: Imatinib Mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Resource links provided by NLM:


Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • Reduction of Haematocrit to less than 45%. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Reduction in platelet count and spleen size. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Reduction of incidence phlebotomies. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Symptoms improvement in patients. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response duration [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Mesylate Drug: Imatinib Mesylate
400 mg/die for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430066

Sponsors and Collaborators
Niguarda Hospital
Investigators
Study Director: Enrica Morra, MD Divisione di Ematologia - Ospedale Niguarda Ca' Granda
  More Information

No publications provided

Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT00430066     History of Changes
Other Study ID Numbers: CSTI571POLIVERA
Study First Received: January 31, 2007
Last Updated: June 18, 2012
Health Authority: Italy: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014